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Diagnostics for Tuberculosis into Class 2

[ Price : $8.95]

Federal Register Final Order: FDA classifies nucleic acid-based in vitro diagnostic devices for MTB-complex into Class 2.

Withdraw Distribution of Scientific Info Guide: Public Citizen

[ Price : $8.95]

Public Citizen says FDA should withdraw its 6/11 draft guidance on distributing scientific and medical publications because it wou...

FDA Accepts Alkermes NDA for Schizophrenia Injectable

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FDA accepts for filing an Alkermes NDA for aripiprazole lauroxil, an investigational, once-monthly injectable atypical antipsychot...

Restrictions Sought on Generic Prepopik

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Ferring asks FDA to require ANDA sponsors to conduct clinical studies to demonstrate bioequivalence of a generic form of its colon...

Lawyers Debate Pinnacle Hips in Trial

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Attorneys for a women who claims design defects in DePuy Pinnacle hips injured her and for the company debate the implants safety ...

Recalled Supplements Sell with Banned Ingredients: Study

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Researchers say that two-thirds of dietary supplements recalled by FDA for containing banned substances still contained those or o...

Court Says Some False Ad Claims Need FDA Expertise

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A California federal court says some Lanham Act false advertising cases require FDA expertise to resolve.

OMB OKs Info on Petitions for Exemption from Preemption

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Federal Register Notice: FDA submits a proposed collection of information on state petitions for exemption from preemption to the ...

Guidance on Developing Drugs for Migraine

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Federal Register Notice: FDA releases a draft guidance for industry entitled Migraine: Developing Drugs for Acute Treatment.

Workshop on Sentinel Initiative

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Federal Register Notice: FDA plans a public workshop 2/5/15: Seventh Annual Sentinel Initiative Public Workshop.